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Stem cell collection in patients with de novo multiple myeloma treated with the combination of bortezomib and dexamethasone before autologous stem cell transplantation according to IFM 2005–01 trial

Leukemia volume 24, pages 1233–1235 (2010)Cite this article

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The aim of the IFM2005-01 phase 3 multicenter study (EudraCT 2005–000537–38, Clinicaltrials.gov NCT00200681) was to compare prospectively efficacy and safety of bortezomib and dexamethasone with vincristine–doxorubicin–dexamethasone (VAD) as induction before autologous stem cell transplantation (ASCT) in patients with previously untreated myeloma less than 66 years of age. The primary end point was post-induction complete response and near-complete response rate. An important issue raised by this study was that of stem cell collection in the bortezomib–dexamethasone arm.1, 2

Patients were centrally randomized (1:1:1:1) to receive VAD induction plus no consolidation (arm A1), VAD plus dexamethasone, cyclophosphamide, etoposide and cis-platinum consolidation (A2), bortezomib–dexamethasone plus no consolidation (B1) or bortezomib–dexamethasone plus dexamethasone, cyclophosphamide, etoposide and cis-platinum consolidation (B2). VAD comprised four 4-week cycles of vincristine 0.4 mg/day and doxorubicin 9 mg/m2/day by continuous infusion, days 1–4, plus dexamethasone 40 mg orally on days 1–4 (all cycles) and 9–12 and 17–20 (cycles 1–2). Bortezomib–dexamethasone comprised four 3-week cycles of bortezomib 1.3 mg/m2 intravenously, days 1, 4, 8 and 11, plus dexamethasone 40 mg on days 1–4 (all cycles) and 9–12 (cycles 1–2). Dexamethasone, cyclophosphamide, etoposide and cis-platinum comprised two 4-week cycles of dexamethasone 40 mg, days 1–4, plus cyclophosphamide 400 mg/m2, etoposide 40 mg/m2 and cis-platinum 15 mg/m2 per day by continuous infusion, on days 1–4. Stem cell mobilization was undertaken with granulocyte-colony-stimulating factor (G-CSF) 10 μg/kg/day from day 15 of the third induction cycle. If stem cell collection was inadequate, a second mobilization was undertaken with cyclophosphamide 3 g/m2 plus G-CSF 5 μg/kg/day after induction cycle 4. The target yield was 5 × 106 CD34+ cells/kg allowing a tandem transplant procedure. Conditioning for the first transplant comprised melphalan 200 mg/m2. Response was evaluated 1–3 months later. A second transplant was not conducted for patients achieving at least very good partial response. Patients achieving less than very good partial response could undergo a second autologous procedure.

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Authors and Affiliations

  1. Hematology Department, University Hospital, Nantes, France

    P Moreau

  2. Hematology Department, University Hospital, Nancy, France

    C Hulin

  3. Hematology Department, University Hospital, Bordeaux, France

    G Marit

  4. Hematology Department, University Hospital, Dijon, France

    D Caillot

  5. Hematology Department, University Hospital, Lille, France

    T Facon

  6. Hematology Department, Centre Henri Bécquerel, Rouen, France

    P Lenain

  7. Hematology Department, University Hospital, Brest, France

    C Berthou

  8. Hematology Department, University Hospital, Grenoble, France

    B Pégourié

  9. Hematology Department, Centre Paoli-Calmettes, Marseille, France

    A M Stoppa

  10. Hematology Department, University Hospital, Bobigny, France

    P Casassus

  11. Hematology Department, University Hospital, Lyon, France

    M Michallet

  12. Hematology Department, University Hospital, Tours, France

    L Benboubker

  13. Hematology Department, University Hospital, La Roche-sur-Yon, France

    H Maisonneuve

  14. Hematology Department, University Hospital, Louvain, Belgium

    C Doyen

  15. Hematology Department, University Hospital, Lausanne, Switzerland

    S Leyvraz

  16. Hematology Department, Institut Curie, Paris, France

    C Mathiot

  17. Hematology Laboratory, University Hospital, Nantes, France

    H Avet-Loiseau

  18. Hematology Department, University Hospital, Toulouse, France

    M Attal

  19. Centre René Gauducheau, Saint-Herblain, France

    J L Harousseau

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Correspondence to P Moreau.

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Moreau, P., Hulin, C., Marit, G. et al. Stem cell collection in patients with de novo multiple myeloma treated with the combination of bortezomib and dexamethasone before autologous stem cell transplantation according to IFM 2005–01 trial. Leukemia 24, 1233–1235 (2010). https://doi.org/10.1038/leu.2010.82

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